Highlights:
- DCGI expert panel to review Covaxin’s 3rd phase trial data on Tuesday
- Bharat Biotech will have a “pre-submission” meeting with WHO for Covaxin’s approval as COVID-19 vaccine
- India had its largest 1-day vaccination drive on Monday breaking all records
The 3rd phase data of Bharat Biotech’s Covaxin will be reviewed today i.e. Tuesday, by the Subject Expert Committee (SEC) under the Drugs Controller General of India (DCGI), as reported by the news agency ANI. Earlier, the agency had also reported that the Hyderabad-based company has already submitted data from its Phase III clinical trials of the COVID vaccine (Covaxin) to the Indian drug regulator.
The meeting comes ahead of the “pre-submission” meet of Bharat Biotech with the World Health Organization (WHO) for the approval of the COVID vaccine.
As per ANI, “The Subject Expert Committee will meet today to review the Phase III data of Covaxin.”
The sources from the government further confirmed that the company had submitted data from the Phase III clinical trials of Covaxin to the drug regulator.
A senior government employee said, “We have received the data from the phase III trials”.
Covaxin, which is developed by Bharat Biotech, is one of the three vaccines which are currently being used in India. The phase 3 data of its vaccine have been questioned various times and that is what makes the data crucial which will ascertain the efficacy of the vaccine.
A few days back, Dr V K Paul, a member of (Health) Niti Aayog, has confirmed that the company would be submitting the data within seven to eight days.
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In May this year, Bharat Biotech had said that an Emergency Use Listing (EUL) application had been submitted to the WHO, with regulatory approvals expected between July and September.
India recorded its highest number of single-day vaccination on Monday
India administered a record 8.3 million (83 lakh) vaccine doses on Monday under a campaign of the central government to inoculate all adults (18 years and older) for free after weeks of criticism that a chaotic rollout had worsened a second wave that killed hundreds of thousands.
The number of people vaccinated on Monday is almost double that of the entire population of New Zealand and Singapore.
Earlier in June, the Prime Minister of India said that the government would be buying 75% of all vaccines from the drug makers and distribute them for free to states, which along with private hospitals had earlier been buying shots for people aged 18-45.
India’s previous record of 4.5 million (45 lakh) doses came on the 5th of April, followed by a sharp decline with average daily inoculation falling below 3 million (30 lakh).
